Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV (ARMAM)

The Washington University

Status: Completed

Conditions: HIV; Kwashiorkor; Marasmus; Severe Acute Malnutrition

Treatments: Drug: zidovudine, lamivudine, nevirapine

Study type: Observational

Funder types: Other

Identifiers

NCT01529125

ARTMAM

Details and patient eligibility

About

It is unclear whether children with HIV and severe acute malnutrition can be started on highly active antiretroviral therapy (HAART) safely while they are still malnourished and the manner in which this therapy should start. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.

Enrollment: 42 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-infected about to start on HAART for the first time
• 6-59 months old

Exclusion criteria

• also being treated for TB
• other chronic illness (e.g., congenital heart disease, cerebral palsy)

Trial design

42 participants in 3 patient groups

Kwashiorkor

Description:

HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.

Treatment:

Drug: zidovudine, lamivudine, nevirapine

Marasmus

Description:

HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.

Treatment:

Drug: zidovudine, lamivudine, nevirapine

Control

Description:

HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason.

Treatment:

Drug: zidovudine, lamivudine, nevirapine